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FLUOCINONIDE
CREAM USP, 0.05%
(Emollient Base)
Rx only
For Topical Use Only
Not for Ophthalmic Use
DESCRIPTION
Fluocinonide Cream USP, 0.05% (Emollient Base) is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)–.
It has the following chemical structure
Fluocinonide Cream USP, 0.05% (Emollient Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid, mineral oil, polysorbate 60, propylene glycol, sorbitan monostearate, stearyl alcohol and purified water.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
INDICATIONS and USAGE
Fluocinonide Cream USP, 0.05% (Emollient Base) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
PRECAUTIONS
Pediatric Use:Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
ADVERSE REACTIONS
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are uled in an approximate decreasing order of occurrence:
| Burning | Perioral dermatitis |
| Itching | Allergic contact dermatitis |
| Irritation | Maceration of the skin |
| Dryness | Secondary infection |
| Folliculitis | Skin atrophy |
| Hypertrichosis | Striae |
| Acneiform eruptions | Miliaria |
| Hypopigmentation |
OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)
DOSAGE AND ADMINISTRATION
Fluocinonide Cream USP, 0.05% (Emollient Base) is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
HOW SUPPLIED
Fluocinonide Cream USP, 0.05% (Emollient Base) is supplied as follows:
| NDC 0168-0246-15 | 15 gram tubes |
| NDC 0168-0246-30 | 30 gram tubes |
| NDC 0168-0246-60 | 60 gram tubes |
Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]
Avoid excessive heat, above 40°C (104°F).
E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NY 11747
I246
#191
R4/04